Assessing Arsenic Trioxide in Young Patients With Leukemia or Lymphoma Who Were Treated on Clinical Trial NCI-00-C-0070J
Sample Analysis for Terminated Protocol 00-C-0070, Pediatric Phase I Trial of Arsenic Trioxide
RATIONALE: Studying bone marrow and blood samples from patients with leukemia or lymphoma treated with arsenic trioxide may help doctors learn more about cancer.
PURPOSE: This research study is assessing arsenic trioxide in young patients with recurrent or refractory leukemia or lymphoma who were treated on clinical trial NCI-00-C-0070J.
研究概览
详细说明
OBJECTIVES:
- To assess the pharmacokinetic and pharmacodynamic profiles of arsenic trioxide in pediatric patients treated on protocol NCI-00-C-0070J.
OUTLINE: Bone marrow or peripheral blood mononuclear cells collected during treatment on NCI-00-C-0070J are assessed for pharmacodynamics studies. Plasma cells collected during treatment are assessed for pharmacokinetics studies. Total arsenic (As), inorganic As forms (AsIII and AsV), and methylated metabolites of As are assessed.
研究类型
注册 (预期的)
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS:
Histologically confirmed leukemia or lymphoma refractory to standard curative treatment regimens
- No meningeal leukemia or lymphoma
- No HIV-related lymphoma
- No lymphoproliferative diseases
- Received treatment on protocol NCI-00-C-0070J
- Bone marrow or peripheral blood and serum samples collected during treatment on NCI-00-C-0070J are available
PATIENT CHARACTERISTICS:
- See NCI-00-C-0070J
PRIOR CONCURRENT THERAPY:
- See NCI-00-C-0070J
学习计划
研究是如何设计的？
研究衡量的是什么？
主要结果指标
结果测量 |
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药代动力学 (PK)
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Pharmacodynamics (PD)
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Correlation of PK and PD with clinical parameters, such as age, gender, and dose
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合作者和调查者
调查人员
- 首席研究员：Elizabeth Fox, MD、National Cancer Institute (NCI)
研究记录日期
研究主要日期
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 999907221
- 07-C-N221
- CDR0000570658
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